BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN

    MDR report key: 9825599 · Received March 12, 2020

    Report

    Report Number
    3006260740-2020-00839
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Report Date
    March 12, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    UDI-DI
    00801741047329
    PMA / PMN Number
    K153440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF ASDRF075 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH "RN ACCESSED PATIENT PORT AND AFTER THE NEEDLE WAS INSERTED, SHE FLUSHED AND THE WHITE CAP CLOSET TO THE NEEDLE/PATIENT FLEW OFF AND SALINE SPRAYED OUT ONTO THE PATIENT'S SHIRT. NORMAL FORCE WAS USED WHEN FLUSHING. PRODUCT: (POWER LOC MAX HUBER NEEDLE 19G 1 INCH, REF#: 0131910, LOT: ASDR075). CAP ON POWER LOC MAX HUBER NEEDLE TUBING PORT CLOSEST TO THE NEEDLE CAME OFF DURING FLUSHING. TUBING DID NOT APPEAR TO BE CRACKED, CAP DID NOT STAY ON AS IT NORMALLY DOES, MAY HAVE BEEN LOOSE OR DEFECTIVE. RN WAS ABLE TO PLACE ANOTHER STERILE CAP IN PLACE OF CAP THAT CAME OFF AND FINISHED FLUSHING PORT. NO PATIENT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285667 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS N/A ASDRF075 00801741047329

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR